Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339469
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2006-06-19
Brief Title:
Effect of High-Legume Diet on Colorectal Cancer Risk
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of a High Legume Low Glycemic Index Diet on Insulin Resistance and Inflammation in Patients at High Risk for Colorectal Adenoma Recurrence
Status:
COMPLETED
Status Verified Date:
2018-02-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study sponsored by the National Cancer Institute and Penn State University will examine how a diet high in legumes dried beans influences risk factors for colon cancer and polyps Many scientists believe that colon and rectal cancers develop from polyps tumors of the lining of the large bowel This study will test whether a high-legume diet can reduce levels of certain factors blood insulin blood glucose and markers of inflammation such as C-reactive protein that at elevated levels are known to increase the risk of colorectal polyps and colon cancer
Healthy men between 35 and 75 years of age may be eligible for this study conducted at Penn State University in University Park Pennsylvania Candidates are screened with blood tests and measurements of height weight and blood pressure All candidates must have had a colonoscopy within 2 years of entering the study They may or may not have had adenomas and may or may not be insulin-resistant Candidates must not have cancer heart disease kidney disease diabetes or other serious medical condition and they must have no history of colorectal cancer polyp removal bowel surgery polyposis syndrome or inflammatory bowel disease Participants undergo the following tests and procedures
Caloric requirement testing The subjects resting metabolic rate is measured while fasting and in the early morning at rest to determine daily calorie requirement before beginning the study diet A special clear plastic hood is placed over the subjects head while his breathing is measured He can communicate with the technician at all times during the 30-minute test
Study diet Subjects follow two required 4-week diets with a 3-week break in between followed by an optional third 4-week diet Subjects eat a healthy American diet for both of the required 4-week diet periods about 1-12 cups of cooked legumes such as pinto baked and navy beans are added to one of the two required diets For the third optional diet period subjects are given the same 1-12 cups of legumes but are allowed to lose weight Participants are given packages with all of the food they are to consume during the three diet periods They may add up to five caffeine-containing beverages per day and up to two alcoholic drinks per week They must eat all of the food they are given and only the food they are given Subjects are expected to maintain a constant body weight during the two 4-week required diets and their caloric intake may be increased or decreased as needed to maintain their screening weight
Weight measurements Subjects are weighed regularly at the clinic
Blood samples Subjects have blood samples drawn at the mid-point of each of the two required 4-week diets and at the beginning and end of each of the three 4-week diets
Urine and stool samples Urine and stool samples are collected at the beginning and end of the two required 4-week diets
Healthy men between 35 and 75 years of age may be eligible for this study conducted at Penn State University in University Park Pennsylvania Candidates are screened with blood tests and measurements of height weight and blood pressure All candidates must have had a colonoscopy within 2 years of entering the study They may or may not have had adenomas and may or may not be insulin-resistant Candidates must not have cancer heart disease kidney disease diabetes or other serious medical condition and they must have no history of colorectal cancer polyp removal bowel surgery polyposis syndrome or inflammatory bowel disease Participants undergo the following tests and procedures
Caloric requirement testing The subjects resting metabolic rate is measured while fasting and in the early morning at rest to determine daily calorie requirement before beginning the study diet A special clear plastic hood is placed over the subjects head while his breathing is measured He can communicate with the technician at all times during the 30-minute test
Study diet Subjects follow two required 4-week diets with a 3-week break in between followed by an optional third 4-week diet Subjects eat a healthy American diet for both of the required 4-week diet periods about 1-12 cups of cooked legumes such as pinto baked and navy beans are added to one of the two required diets For the third optional diet period subjects are given the same 1-12 cups of legumes but are allowed to lose weight Participants are given packages with all of the food they are to consume during the three diet periods They may add up to five caffeine-containing beverages per day and up to two alcoholic drinks per week They must eat all of the food they are given and only the food they are given Subjects are expected to maintain a constant body weight during the two 4-week required diets and their caloric intake may be increased or decreased as needed to maintain their screening weight
Weight measurements Subjects are weighed regularly at the clinic
Blood samples Subjects have blood samples drawn at the mid-point of each of the two required 4-week diets and at the beginning and end of each of the three 4-week diets
Urine and stool samples Urine and stool samples are collected at the beginning and end of the two required 4-week diets
Detailed Description:
Clinical epidemiological and molecular studies provide compelling evidence that most colorectal cancers arise from adenomas The epidemiology of adenomas closely resembles that of colorectal cancer itself and prevention of adenomas will most likely prevent colorectal cancer Insulin resistance and type 2 diabetes are emerging as significant risk factors for colorectal CRC cancer and adenomas Insulin resistance is defined as impaired biological response to the action of insulin It is characterized by compensatory hyperinsulinemia and is associated with increased risk for Type 2 diabetes C-peptide a marker of insulin production is elevated in IR and is also a risk factor for CRC Both insulin resistance and colorectal cancer are increasingly recognized as chronic low-level inflammatory states C-reactive protein CRP an acute phase protein and a sensitive marker of sub-clinical inflammation is a risk factor for both IR and CRC
Analysis from the Polyp Prevention Trial PPT a multi-center randomized trial of 1905 participants who had a colorectal adenoma showed that legume consumption was significantly associated with reduction of both adenoma recurrence and advanced adenoma recurrence Legumes are a rich source of dietary fibers and anti-inflammatory anti-cancer phytochemicals
We are evaluating the effects of a legume enriched low glycemic index high fermentable fiber diet on CRP a measure of inflammation and C-peptide a measure of insulin resistance in participants with four possible combinations of the risk factors insulin resistance and history of adenomatous polyps In a randomized crossover design controlled feeding study each participant consumed the above experimental diet and a control diet for four weeks with a two week washout period between diets 65 male participants were recruited and randomized into four groups A secondary objective is to assess whether these endpoints change by IR status or a history of adenomas In addition potential fecal markers of CRC risk are being measured to assess changes in gastrointestinal inflammation including mRNA from exfoliated fecal colonocytes To our knowledge this is the first controlled feeding study 1 to examine the effects of legumes or a low GI diet on markers of inflammation 2 to compare the effects of a dietary intervention on patients with a history of colon adenomas with or without IR and 3 to measure the effects of dietary changes in human intestinal gene expression profiles using exfoliated colonocytes
Analysis from the Polyp Prevention Trial PPT a multi-center randomized trial of 1905 participants who had a colorectal adenoma showed that legume consumption was significantly associated with reduction of both adenoma recurrence and advanced adenoma recurrence Legumes are a rich source of dietary fibers and anti-inflammatory anti-cancer phytochemicals
We are evaluating the effects of a legume enriched low glycemic index high fermentable fiber diet on CRP a measure of inflammation and C-peptide a measure of insulin resistance in participants with four possible combinations of the risk factors insulin resistance and history of adenomatous polyps In a randomized crossover design controlled feeding study each participant consumed the above experimental diet and a control diet for four weeks with a two week washout period between diets 65 male participants were recruited and randomized into four groups A secondary objective is to assess whether these endpoints change by IR status or a history of adenomas In addition potential fecal markers of CRC risk are being measured to assess changes in gastrointestinal inflammation including mRNA from exfoliated fecal colonocytes To our knowledge this is the first controlled feeding study 1 to examine the effects of legumes or a low GI diet on markers of inflammation 2 to compare the effects of a dietary intervention on patients with a history of colon adenomas with or without IR and 3 to measure the effects of dietary changes in human intestinal gene expression profiles using exfoliated colonocytes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-N215 | None | None | None |